Senior Quality Engineer
Core
Lead and coordinate operations quality investigations, drive root cause analysis, and ensure compliance with regulations for medical device manufacturing.
Role type
Senior Quality Engineer (Operations)
Builds
Quality tools, training materials, and corrective action plans for Arden Hills operations.
Domain
Medical Devices / Manufacturing Quality
Required skills
Root cause analysis, regulatory compliance, process improvement, technical mentorship, audit support, data analysis, risk-based decision-making, cross-functional partnership
Responsibilities
Coordinate Product Inquiry Reports (PIRs) for Arden Hills operations to investigate quality issues and drive decisions on corrective actions. Serve as the Arden Hills operations process owner for the PIR process, providing guidance and mentorship across the site. Identify and lead projects to improve quality outcomes by reducing manufacturing defects and partnering cross-functionally to drive product improvements. Provide technical mentorship to engineers on problem-solving and risk-based decision-making. Serve as a subject matter expert in the front room during audits with external bodies. Evaluate the adequacy and compliance of systems, operations and practices against applicable regulations and company documentation. Apply an understanding of external regulations to drive decision-making and technical solutions. Create quality tools and training materials by applying technical expertise and communicating effectively with respective teams. Perform appropriate analyses to identify trends, improvement opportunities and corrective actions.